Flotetuzumab Expanded Access Program

NCT04678466 | Unknown

• 1 other identifier: MGD006-EA
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the Expanded Access program is to provide flotetuzumab to patients with acute myeloid leukemia (AML) for whom potential benefit justifies potential treatment risks.

Conditions

Acute Myeloid Leukemia; AML; AML, Adult Recurrent

Interventions

flotetuzumab BIOLOGICAL

CD123 x CD3 bispecific DART® antibody

Also known as: MGD006

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight of at least 17 kilograms
• CD123-positive hematologic malignancy
• Adequate organ reserve
• Provider and site are trained on study protocol using flotetuzumab

You may not qualify if:

• Primary induction failure
• Early relapse (less than 6 months after first complete remission )
• Three prior lines of therapy, including maximum of 1 prior salvage attempts

Sponsors & Collaborators

• MacroGenics: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashley Ward, MD

  MacroGenics

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 22, 2020
• Last Updated: May 31, 2022

Record last verified: 2022-05